Awl-tipped pedicle screw and method of implanting same

ABSTRACT

A bone screw and method of inserting the same is disclosed. In one example, the bone screw includes an awl tip for creating a pilot hole in the pedicle of a vertebra without having to predrill a starter hole. One or more threads located adjacent to the awl tip engage the wall of the pilot hole and draw the screw into the bone, thereby eliminating the need to drill and tap a hole in the bone prior to implantation of the screw.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of and claims priority toco-pending U.S. patent application Ser. No. 13/117,669 filed on May 27,2011, which claims priority to U.S. Provisional Pat. No. 61/396,564filed on May 28, 2010.

FIELD

The claimed technology relates generally to medical devices and moreparticularly to bone screws and methods of implanting the same.

BACKGROUND

A variety of threaded fasteners have been developed for use inorthopedic surgical procedures to secure bone fragments, reattachligaments or soft tissue to bones, or to hold bones in relative positionto one another. One variety of bone screws used in the vertebrae of thespine are called pedicle screws, so named because they are inserted intothe pedicle of the vertebral body. Pedicle screws are commonly usedalong with rods and screws to immobilize a portion of the spinal column.In other applications, pedicle screws are inserted into a series ofvertebrae and one or more metal rods are secured to the heads of thescrews, typically using set screws or some other securing means.

Current pedicle screw designs require multiple steps to insure properimplantation into the vertebral body. Typically, an entry point is madeinto the pedicle using a high speed drill bit or an awl to create apilot hole. In some instances, the pilot hole is enlarged using largerdiameter drill bits. The pilot hole may then be probed with aninstrument to detect any breaches in the pedicle wall. After theintegrity of the pilot hole wall is confirmed, the pilot is then tappedto create a track in the hole wall for the screw to follow using a tap.Finally, the screw may be implanted into the prepared hole.

Every surgical procedure carries with it a risk of complications.Procedures which require multiple steps such as pedicle screwimplantation create the potential for the patient to experiencecomplications with each step. Additionally, the chances for a surgeon tomake a mistake due to fatigue during long procedures involving multiplescrews increases with the number of steps required for placement of eachscrew. Thus there is a need for an improved bone screw which reduces thenumber of steps required for implantation of the screw into bone.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a bone screw according to one embodiment of thedisclosed invention.

FIG. 2 is a perspective view of the bone screw shown in FIG. 1.

FIG. 3 is a side view of a bone screw according to another embodiment ofthe disclosed invention.

FIG. 4 is a perspective view of the bone screw shown in FIG. 3.

FIG. 5 is a side, cross sectional view of a bone screw being insertedinto the pedicle of a spine according to one embodiment of the disclosedinvention.

FIG. 6 is a side and perspective view of another embodiment of thedisclosed invention.

FIG. 7 is a side view of yet another embodiment of the disclosedinvention.

FIG. 8 is a partial view of tips according to other embodiments of thedisclosed invention.

DESCRIPTION

For the purposes of promoting an understanding of the principles of theclaimed technology and presenting its currently understood best mode ofoperation, reference will now be made to the embodiments illustrated inthe drawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of the scope of theclaimed technology is thereby intended, with such alterations andfurther modifications in the illustrated device and such furtherapplications of the principles of the claimed technology as illustratedtherein being contemplated as would normally occur to one skilled in theart to which the claimed technology relates.

A bone screw 10 according to one embodiment of the disclosed inventionis shown in FIG. 1. In the following description, the term “distal” willrefer to the direction towards which a screw is designed to be advancedas the screw is engaged to bone and “proximal” will refer to theopposite direction. Bone screw 10 comprises several segments or portionswhich begin at a distal end 12 and extend along a longitudinal axis 20to a proximal end 14. Located at distal end 12 of bone screw 10 is a tipportion 40 comprising an awl tip 30 and a helical, radiallyoutward-extending thread 80. The awl tip is sized and configured so asto be capable of cutting, boring, or otherwise creating a pilot holewhen placed against bone and torsional and/or downward force is appliedto the screw, thereby eliminating the need for the separate steps forplacing a pilot hole, drilling, probing, and tapping the hole duringimplantation. In some examples, the leading or distal edge 82 of thethread 80 begins at the proximal edge 32 of the awl tip 30. In otherexamples, the thread actually overlaps a portion of the awl tip.Typically, the leading edge of the thread is positioned such that as theawl tip excavates a hole in the bone, the leading edge engages the wallsof the hole and draws the screw body into the bone. A variety ofdifferent thread styles and patterns may be used, including self-tappingthreads, dual threads, and other suitable thread designs known in theindustry. Optionally, tip portion 40 further includes one or more flutes70 for conveying bone material away from the awl tip 30 and/or thread 80during insertion of the screw into bone. In some examples, the flute 70may also include a cutting edge 75 for engaging and removing bonematerial. The flute show in FIG. 1 is longitudinally disposed in thesurface of the screw along axis 20, however other shapes, styles, andconfigurations of fluting may be used.

Adjacent to the proximal end of tip portion 40 is the distal end of ashank portion 50. The thread 80 from tip portion 40 continues throughshank portion 50 to approximately the head portion 60 in this particularexample. In other examples, a part of shank portion 50 may beunthreaded. Optionally, flute 70 which begins in tip portion 40 maycontinue or extend through a portion or all of shank portion 50.Adjacent to the proximal end of shank portion 50 and is the distal endof a head portion 60. In this particular embodiment, head portion 60 isshown comprising a U-shaped rod fixation element having a cradle 100 forreceiving and securing rods (not shown) such as those commonly used inspinal procedures. Cradle 100 may further include a locking portion 120(as shown in FIG. 2) for receiving and securing a locking member (notshown), such as a set screw, using a variety of locking means such asthreads, bayonet style closure, and the like. Even though a fixed,U-shaped head assembly is shown in the present example, it is understoodthat other types and styles of head assemblies may also be used with thedisclosed invention such as a polyaxial head assembly, a hex headassembly, and any other mono-axial, mutli-axial, or fixed head design asknown in the art.

A bone screw 130 according to another embodiment of the disclosedinvention is shown in FIG. 3. Bone screw 130 comprises several segmentsor portions which begin at a distal end 136 and extend along alongitudinal axis 132 to a proximal end 134. Located at distal end 136of bone screw 130 is a tip portion 140 comprising an awl tip 170 and ahelical, radially outward-extending thread 200. A variety of differentthread styles and patterns may be used, including self-tapping threads,dual threads, and other suitable thread designs known in the industry.Optionally, tip portion 140 further includes one or more flutes 180 forconveying bone material away from the awl tip 170 and/or thread 200during insertion of the screw into bone. In some examples, the flute 180may also include a cutting edge 190 for engaging and removing bonematerial. The flute show in FIG. 3 is an axially wound or spiral fluteabout the central body of screw 130 disposed along axis 132.

Adjacent to tip portion 140 is a shank portion 150. The thread 200 fromtip portion 140 continues through shank portion 150 to approximately thehead portion 160 in this particular example. In other examples, a partof shank portion 150 may be unthreaded. Flute 180 which begins in tipportion 140 continues through a portion of shank portion 150. Adjacentto shank portion 150 and continuing to the proximal end 134 of screw 130is a head portion 210. In this particular embodiment, head portion 210is shown comprising a U-shaped rod fixation element having a cradle 220for receiving and securing rods (not shown) such as those commonly usedin spinal procedures. Cradle 220 may further include a locking portion230 (as shown in FIG. 4) for receiving and securing a locking member(not shown) using a variety of locking means such as threads, bayonetstyle closure, and the like. Even though only a U-shaped head assemblyis shown in the present example, it is understood that other types andstyles of head assemblies may also be used with the disclosed inventionsuch as a polyaxial head assembly, hex head assembly, and the like.

Screw Implantation

Placement of a bone screw according to the presently disclosed inventiondoes not require the multi-step procedure commonly used in the industryand previously described. One method of implanting a bone screwaccording to the presently disclosed invention comprises placing the awltip against the vertebra at the desired entry point, typically at thesurface of a pedicle. Torsional force is applied to the bone screw usinga driving tool engaged with the head of the screw. Typically the drivingtool will be an image guided and navigated tool, such as a screw driver,to allow the surgeon to confirm the correct trajectory of the screwthrough the bone. In other examples, guidance techniques such asanatomic landmarks or fluoroscopy may also be used to insure properscrew placement. As torsional force is applied to the screw, the awl tipengages and begins to carve a hole into the bone. Once the awl hascarved a hole of sufficient depth the threads will engage the bone.Typically, the thread (or threads if a multi-thread design is used) ofthe screw begin immediately adjacent to the awl tip so as to reduce thedepth to which the screw must be driven before the screw engages thebone.

Once the screw threads have engaged the bone, the threads act to drawthe screw down into the vertebra while the awl tip continues to carveout bone at the tip of the screw. If the screw also includes one or moreflutes, the flutes act to channel bone material away from the tip andthread so as to increase performance of the screw. As the threads act topull the screw down into the bone less force will need to be applied bythe surgeon. Proper placement of the screw can be confirmed usingimaging. Additional confirmation may be provided using neuromonitoringto insure there is no nerve irritation. Once the desired implantationdepth is reached, additional elements such as rods, plates, and thelike, may be secured to the screw using appropriate means.

FIG. 5 shows the implantation of a bone screw in a vertebra according toone embodiment of the disclosed invention. In this particular example, abone screw 250 such as those previously described is implanted invertebra 240. An awl tip 270 allows the screw 250 to be driven into thebone of the vertebra, specifically through the body of a pedicle 242 andinto the vertebral body 244. Bone screw 250 includes a head portion 260which is configured and adapted to engage a suitable driving tool 280which allows for implantation of the screw. Optionally, driving tool 280is an image guided and navigated tool, such as a screw driver, to allowfor confirmation of the trajectory of the screw through the pedicle.Image guided navigation allows a surgeon to confirm proper placement ofthe screw in the bone. Additionally, the harder cortical bone walls ofthe pedicle will encourage the screw to follow a trajectory through thesofter, cancellous bone found in the center of the pedicle. Imaging maybe used to confirm proper screw placement. Additionally, neuromonitoringmay be used to confirm there is no nerve root irritation while the screwis being placed. Once placed, additional elements such as rods, plates,and the like, may be secured to the screw using appropriate means.

Reducing the number of steps in the implantation procedure using thedevices and methods previously described decreases the time required fora procedure. Less time in the operating room means less blood loss,decreased risk of infection and the patient spends less time sedated,thereby reducing the possibility of anesthesia-related complications.Elimination of preparatory steps required for the placement of currentbone screw designs also decreases the opportunities for mistakes duringimplantation, especially during long procedures involving theimplantation of multiple screws where surgeon fatigue can become afactor.

While the claimed technology has been illustrated and described indetail in the drawings and foregoing description, the same is to beconsidered as illustrative and not restrictive in character. It isunderstood that the embodiments have been shown and described in theforegoing specification in satisfaction of the best mode and enablementrequirements. It is understood that one of ordinary skill in the artcould readily make a nigh-infinite number of insubstantial changes andmodifications to the above-described embodiments and that it would beimpractical to attempt to describe all such embodiment variations in thepresent specification. Accordingly, it is understood that all changesand modifications that come within the spirit of the claimed technologyare desired to be protected.

What is claimed is:
 1. A bone screw, comprising: a tip portion,comprising an awl tip capable of creating a hole in bone; a shankportion proximate to said tip portion; a head portion proximate to saidshank portion; and at least one helical thread which begins at said tipportion and continues through said shank portion.
 2. The bone screw ofclaim 1, wherein said tip portion further comprises at least one flute.3. The bone screw of claim 2, wherein said flute extends into said shankportion.
 4. The bone screw of claim 3, wherein said flute is a spiralflute.
 5. The bone screw of claim 2, wherein said flute furthercomprises a cutting edge.
 6. The bone screw of claim 1, wherein saidhead portion is adapted and configured to receive an image guided drivetool.
 7. A pedicle screw, comprising: a tip portion located at thedistal end of said pedicle screw, comprising a tip capable of starting ahole in bone; a head portion located at the proximate end of saidpedicle screw; a shank portion disposed between said tip portion andsaid head portion; and at least one thread beginning on said tip portionand continuing in said shank portion.
 8. The pedicle screw of claim 7,wherein said tip portion further comprises at least one flute.
 9. Thepedicle screw of claim 8, wherein said flute extends into said shankportion.
 10. The pedicle screw of claim 9, wherein said flute is aspiral flute.
 11. The pedicle screw of claim 8, wherein said flutefurther comprises a cutting edge.
 12. The pedicle screw of claim 7,wherein said head portion is adapted and configured to receive an imageguided drive tool.
 13. A bone screw, comprising: a tip portion,comprising an awl tip and at least one thread; a shank portion, locatedproximate to said tip portion and comprising part of the at least onethread of the tip portion; and a head portion proximate to said shankportion and adapted to receive a driving tool; wherein said awl tipcreates a hole in bone when torsional force is applied to the screw;wherein said at least one thread is disposed on said tip portion suchthat said thread engages the walls of the hole created by said awl tipand draws the screw into bone.
 14. The bone screw of claim 13, whereinsaid tip portion further comprises at least one flute.
 15. The bonescrew of claim 14, wherein said flute extends into said shank portion.16. The bone screw of claim 15, wherein said flute is a spiral flute.17. The bone screw of claim 13, wherein said at least one thread beginson said awl tip.
 18. The bone screw of claim 13, wherein said at leastone thread begins adjacent to the proximal end of said awl tip.